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| Name | Class |
|---|---|
| California Walnut Commission | OTHER |
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The objective is to investigate the effect of walnuts on gut microbiota, inflammatory markers, atopic dermatitis status, and indices of allergy outcomes in breastfed infants during early complementary feeding.
The three primary aims include:
Aim 1: Evaluate the effect of walnut consumption on gut microbiota structure and function, inflammation, atopic dermatitis, and allergy outcomes.
Aim 2: Evaluate the impact of walnut consumption on infant growth trajectories and risk of overweight.
Aim 3 (exploratory): Identify walnut-specific food signatures that are associated with gut microbiota and immunity biomarkers using a novel nutri-metabolomics technique.
Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The walnut group | Experimental | The intervention group will provide 10g of walnuts daily to their infant for 7 months. |
|
| Control Group | No Intervention | The control group will be asked to limit walnuts and tree nuts. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant walnut intake | Other | The intervention group will receive walnuts at 10 g/day, and the control group will be advised to avoid walnuts/tree nuts during the intervention. The purpose of this research is to learn more about how walnuts as a first food in infants impact immunity and the development of bacteria living in your baby's gut. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing | 16S rRNA amplicon sequencing is used to profile taxonomic makeup of fecal specimens. Within the gut microbiome composition, microbial diversity will be summarized using common ecological measures (Good's coverage, Sobs, and Shannon alpha diversity). | Over 7 months |
| Infant Growth (Length) | Measured in cm | Over 7 months |
| Infant Growth (Weight) | Measured in kg | Over 7 months |
| Dietary Intake | 3 day dietary recall with results generated by NDSR software | Over 7 months |
| IL-33 (Interleukin-33) | Measured in pg/mL | Over 7 months |
| IL-6 (Interleukin-6) | Measure in pg/mL | Over 7 months |
| IL-8 (Interleukin-8) | Measured in pg/mL | Over 7 months |
| IL-13 (Interleukin-13) | Measured in pg/mL | Over 7 months |
| TGF-b (Transforming growth factor beta) |
| Measure | Description | Time Frame |
|---|---|---|
| Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis | Metabolomics analysis (nutri-metabolomics) is used to identify and validate food-derived biomarkers that may be classified as biomarkers of intake and/or biomarkers of effect, both of which can be linked to health indicators. | Over 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathan Campbell, MS | Contact | 7655436716 | Nathan.Campbell@colostate.edu | |
| Kinzie Matzeller, MS RDNCLC | Contact | kinzie.matzeller@colostate.edu |
| Name | Affiliation | Role |
|---|---|---|
| Minghua Tang, Phd | Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food Science and Human Nutrition Clinical Research Laboratory | Recruiting | Fort Collins | Colorado | 80523 | United States |
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|
Measured in ng/ml. |
| Over 7 months |
| IL-4 (Interleukin-4) | Measured in pg/mL | Over 7 months |
| IL-10 (Interleukin 10) | Measured in pg/mL | Over 7 months |